NCT01148459已完成3 期
Safety and Immunogenicity Study of GSK Biologicals' Plasmodium Falciparum Malaria Vaccine 257049 Administered to HIV Infected Infants and Children
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Number of Subjects With Serious Adverse Events (SAEs)
研究概览
简要总结
The purpose of this study is to assess the safety and immunogenicity of the candidate malaria vaccine in HIV-infected infants and children
详细描述
This protocol posting has been updated due to protocol Amendment 2.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Weeks 至 17 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All subjects must satisfy ALL the following criteria at study entry:
- •A male or female infant or child between and including 6 weeks to 17 months of age, at the time of first vaccination.
- •Signed or thumb-printed informed consent obtained from the parent(s)/LAR(s) of the infant or child. Where parents/LARs are illiterate, the consent form will be countersigned by a witness.
- •Subjects who the investigator believes that their parents/LARs can and will comply with the requirements of the protocol should be enrolled in the study.
- •Subjects who are known to be HIV-infected (documented positive DNA PCR), whether taking HIV antiretroviral treatment (ART) or not.
- •Subjects who are born following a normal gestation period.
排除标准
- •The following criteria should be checked at the time of study entry. If ANY exclusion criterion applies, the subject must not be included in the study:
- •Acute disease at the time of enrolment. However, the presence of an illness listed as Grade I or Grade II (WHO pediatric AIDS clinical staging) will not of itself constitute an exclusion criterion. Enrolment should be deferred if axillary temperature is >=37.5°C.
- •Grade III or Grade IV abnormality on screening laboratory blood sample.
- •Grade III or IV AIDS at the time of enrolment (WHO pediatric AIDS clinical staging).
- •Major congenital defects.
- •Planned administration/administration of a vaccine not foreseen by the study protocol prior to or within 7 days of study vaccine.
- •Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine 30 days preceding Dose°1 of study vaccine, or planned use during the study period.
- •Previous participation in any other malaria vaccine trial.
- •Simultaneous participation in another clinical trial including administration of experimental treatment.
- •Same sex twins.
- •History of allergic reactions (significant IgE-mediated events) or anaphylaxis to previous immunizations.
- •History of allergic disease or reactions likely to be exacerbated by any component of the study vaccine.
- •Child in care.
研究组 & 干预措施
Group A
Experimental
Infants enrolled to this group will receive 3 doses of the experimental vaccine.
干预措施: GSK Biological's Investigational Malaria Vaccine 257049 (Biological)
Group B
Active Comparator
Infants enrolled to this group will receive 3 doses of the rabies comparator vaccine.
干预措施: Human Diploid Cell Vaccine (HDCV) or Purified Vero Cell Rabies Vaccine (PVRV, Verorab) (Aventis Pasteur); (Biological)
Group B
Active Comparator
Infants enrolled to this group will receive 3 doses of the rabies comparator vaccine.
干预措施: Purified Chick Embryo Cell Culture (PCEC) Rabies Vaccine (Rabipur or equivalent) (Novartis). (Biological)
结局指标
主要结局
Number of Subjects With Serious Adverse Events (SAEs)
时间窗: During the entire study period (from 30 days before Dose 1 up to Month 14)
SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
次要结局
- Anti-circumsporozoite Protein of P. Falciparum (Anti-CS) Antibody Concentrations(Prior to vaccination (PRE) and one month post Dose 3 (Month 3))
- Number of Episodes With Severe Malaria According to Primary Case Definition(From Day 0 to Month 14)
- Number of Subjects Affected by Prevalent Parasitemia and Prevalent Moderate Anemia(12 months post Dose 3 (Month 14))
- Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Titers(Prior to vaccination (PRE) and one month post Dose 3 (Month 3))
- Anti-CS Antibody Concentrations(12 months post Dose 3 (Month 14))
- Number of Episodes With Clinical Malaria Disease According to Primary Case Definition(From Day 0 to Month 14)
- Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms(During the 7-day post-vaccination period following each dose and across doses: Day 1 through Day 7, Month 1 through Month 1 + 7 days (Day 37), Month 2 through Month 2 + 7 days (Day 67))
- Number of Subjects With Any Unsolicited Adverse Events (AEs)(During the 30-day post-vaccination period (up to Day 90))
- Anti-HBs Antibody Titers(12 months post Dose 3 (Month 14))
- Prevalent Hemoglobin Level(12 months post Dose 3 (Month 14))
- Number of Subjects With Any and Grade 3 Solicited Local Symptoms(During the 7-day post-vaccination period following each dose and across doses: Day 1 through Day 7, Month 1 through Month 1 + 7 days (Day 37), Month 2 through Month 2 + 7 days (Day 67))
- Number of Subjects With Non-malaria Related SAEs(During the entire study period (from 30 days before vaccine Dose 1 up to Month 14))
- Asexual P. Falciparum Parasitemia Density(12 months post Dose 3 (Month 14))
- HIV Viral Load(At baseline (PRE) and at one month (Month 3), 6 months (Month 8) and 12 months (Month 14) post Dose 3)
- Percentage of CD4+ Cells(At baseline (PRE) and at one month (Month 3), 6 months (Month 8) and 12 months (Month 14) post Dose 3)
- CD4+ Absolute Cell Counts(At baseline (PRE) and at 1 month (Month 3), 6 months (Month 8) and 12 months (Month 14) post Dose 3)
- World Health Organization (WHO) HIV Clinical Classification Progression(At baseline (PRE), at study months 1 (Month 1) and 2 (Month 2) and at 1 month (Month 3), 6 months (Month 8) and 12 months (Month 14) post Dose 3)
- Growth Parameters: Weight, Age/Length and Middle Upper Arm Circumference for Age Z-score(At baseline (PRE), at Month 3 and at study end (Month 14))
研究者
研究点 (2)
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